This SBIR project is developing a system capable of remotely monitoring, in real-time, the adherence of an HIV patient to Antiretroviral therapy (ART). ART is a medication regimen that once started, needs to be followed for the rest of the patient's life. ART has been successful in improving the quality and expectancy of life of HIV patients as well as in reducing the likelihood of transmission of the disease. However, its success depends on high levels of adherence to the medication regimen, which is often difficult for patients to accomplish. For this reason, researchers have argued that real-time monitoring of adherence could have a positive impact on their ability to measure adherence and on patients' adherence performance. This project proposes to accomplish real-time monitoring of adherence using a system that integrates sensors, wireless communications, and Internet technologies. The proposed system will be capable of acquiring information about patient's medication consumption and communicating such information to the appropriate personnel for real-time monitoring of adherence. The proposed system addresses several usability and sensing limitations of competing approaches. In particular, it will be capable of measuring partial dosing, which can only be measured through patient reporting today. This system will be designed and tested by the research team that K&A Wireless has put together for this project, which involves experts on sensing, electronic design, wireless and Internet communications, and HIV ART adherence. The Phase 1 effort of this SBIR has proven that the proposed technology is feasible: 1) The sensing and processing approach used to estimate the pill-taking have been successfully developed and tested. 2) The electronics capable of acquiring, processing, and transmitting the medication consumption information have been designed and shown to be portable; and 3) The communication system to implement the remote real- time monitoring of adherence has been specified in detail taking usability, reliability, and information privacy into account. The information obtained from the completion of these milestones has been used to determine the target configuration of all the components of the system and to plan the proposed Phase 2. This Phase 2 will be focused on the full development of the proposed system and on the validation of the usability and accuracy of the system in the field. For this purpose, this Phase 2 effort has th following milestones: 1) Assemble each of the components of the proposed system; 2) Integrate all the components into a fully working system; 3) Evaluate the acceptability of the developed system with providers and patients; and 4) Conduct a validation trial to evaluate the accuracy of the proposed system in the field. In this form K&A Wireless expects to deliver by the end of this Phase 2 effort a working system with demonstrated adherence measuring accuracy, which can then be used to monitor, and even improve ART adherence. PUBLIC HEALTH RELEVANCE: The success of antiretroviral therapy in improving the life of HIV patients depends on high levels of adherence to the medication regimen [3, 4, 5]. Since such adherence requirements are challenging for the patient, researchers have suggested that real-time monitoring of adherence could positively impact adherence measurement accuracy and adherence rates [6]. This motivates the development of a system capable of keeping track of the patient's medication consumption through sensing technology and reporting such information to the provider in real-time.